Regulatory Affairs Manager
2 weeks ago
Position Overview
To be successful in this role, you should have at least ten years of experience in the pharmaceutical industry or a related field. You should also have knowledge of FDA cGMP requirements, ISO standards, ICH guidelines, and quality management systems. You should have excellent communication, grammar, spelling, and problem-solving skills, and be able to work independently or as part of a team.
This is a full-time position based in Santa Ana/Costa Mesa, California.
The role of a Regulatory Affairs Manager is crucial in ensuring that our products comply with regulations and laws governing their manufacturing, sale, and distribution. We specialize in New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), International drug approvals, and 503B outsourcing of non-approved drugs, here are the key responsibilities, experience requirements, and other important aspects for this position:
Duties and Responsibilities:
o Regulatory Strategy Development: The Regulatory affairs manager will develop and implement regulatory strategies to facilitate the approval, registration, and commercialization of products in compliance with applicable regulatory requirements. The successful candidate will assess regulatory risks, evaluate regulatory pathways, and advise senior management on strategies to achieve regulatory objectives while minimizing delays and obstacles.
o Regulatory Submissions and Compliance: The successful candidate will prepare, review, and submit regulatory documents, applications, and dossiers to regulatory agencies for product approvals, registrations, and licenses. You will ensure that department submissions are accurate, complete, and in compliance with regulatory guidelines and requirements. Additionally, regulatory affairs manager will oversee and maintain regulatory compliance throughout the product lifecycle by monitoring changes in regulations and implementing necessary updates.
o Liaison with Regulatory Agencies: The regulatory affairs manager serves as the primary point of contact for communication and interaction with regulatory agencies (such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)). They represent the company in regulatory meetings, discussions, and negotiations, and provide responses to regulatory inquiries and requests for information.
o Cross-Functional Collaboration: The regulatory affairs manager collaborates with cross-functional teams within the organization (including research and development, quality assurance, manufacturing, marketing, and legal departments) to ensure alignment and coordination on regulatory matters.
o Leadership: This position requires the regulatory affairs manager to exhibit empathy, self-awareness, social skills, understand team dynamics, manage conflicts, and foster a positive work environment by encouraging collaboration, promote trust, and empower team members to excel.
Experience Required:
o At least 10 years of experience in pharmaceutical regulatory affairs. Regulatory experience in aseptic manufacturing is beneficial.
o Knowledge of regulatory processes and requirements in different regions or countries.
o Experience in preparing and submitting regulatory submissions.
o Understanding of clinical trial regulations and processes (if applicable to the industry).
Other Important Requirements:
o Master's degree in a related field (such as pharmaceuticals, healthcare, biomedical engineering, chemistry).
o Strong communication and interpersonal skills.
o Knowledge of relevant pharmaceutical laws and regulations.
o Proficiency in data analysis.
o Business Acumen and willingness to be an advocate for or the organization's interests while respecting regulatory boundaries.
In summary, a successful regulatory affairs manager combines technical expertise with leadership skills to maintain excellence, foster growth, and ensure compliance within their department and the broader organization.
Our Client offers a competitive salary, advancement opportunities, and a comprehensive benefits package.
Enjoy excellent working conditions. Semi-flexible hours, full-time day shift, Monday to Friday. Santa Ana/Costa Mesa area.
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